Hemo-O-Lock & Endowrist Clip Applier
Brand(s)
Last updated
Summary
Product
Hemo-O-Lock & Endowrist Clip Applier
Issue
Medical devices - Performance issue
What to do
If instruments cannot be manipulated in a precise and controlled manner, return it to manufacturer.
Audience
Healthcare
Affected products
Affected products | Lot or serial number | Model or catalog number |
---|---|---|
Large Hem-O-Lock Clip Applier | All lots. | 420230 |
Endowrist Medium-Large Clip Applier | All lots. | 420327 |
Small Clip Applier | All lots. | 420003 |
Clip Applier | All lots. | 470230, 470327, 470401 |
Issue
Intuitive has become aware of the potential for unexpected motion caused due to partial disengagement of the instrument from the system while using the da vinci s/si and x/xi Endowrist clip applier instruments. Intuitive has received several complaints on the issue, which indicated non intuitive motion during an attempt to close the grips of the instrument and place a clip.
Recall start date: July 1, 2022
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Health products - Medical devices - General hospital and personal use
Companies
Intuitive Surgical Inc.
1266 Kifer Road, Sunnyvale, California, United States, 94086
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-64345